Generic Drug Product Development
Marcel Dekker Inc (Verlag)
978-0-8247-5460-0 (ISBN)
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Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
Introduction to Generic Drug Development Leon Shargel and Izzy Kanfer; Active Pharmaceutical Ingredients Edward Cohen and Lih-Yang Lin; Analytical Methods Development and Validation Nicholas Cappuccino; Experimental Formulation Development Izzy Kanfer, Peter H.R. Persicaner, and Roderick B. Walker; Scale-up, Technology Transfer and Validation Salah U. Ahmed, Venkatesh Naini, and Dilip Wadgaonker; Product Stability Pranab K. Bhattacharyya; Quality Control and Quality Assurance Loren Gelber and Joan Janulis; Drug Product Performance, In Vitro Pradeep Sathe, Larry Ouderkirk, Ajaz Hussain, and Lawrence X.Yu; ANDA Regulatory Approval Process Timothy W. Ames, Karen A. Bernard, Beth Fabian Fritsch, Koung Lee, Aida L. Sanchez, Krista M. Scardina, and Martin Shimer; Bioequivalence and Drug Product.
| Erscheint lt. Verlag | 28.12.2004 |
|---|---|
| Reihe/Serie | Drugs and the Pharmaceutical Sciences |
| Zusatzinfo | 5 Halftones, black and white |
| Verlagsort | New York |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 658 g |
| Themenwelt | Technik |
| ISBN-10 | 0-8247-5460-3 / 0824754603 |
| ISBN-13 | 978-0-8247-5460-0 / 9780824754600 |
| Zustand | Neuware |
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